MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1

Model Number 801040

Device Problem Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) opened the tube clamp and cleaned the cardioplegia fluid from clamp and lubricated it.This did not correct the clamping action.The fsr replaced the tube clamp.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump showed a 'pump jam' message.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Additional information received from the manufacturer's field service representative (fsr) stated that the tube clamp was the cause of the pump jam.During laboratory analysis, the product surveillance technician (pst) observed the roller pump to have poor close tension on the tube clamp.The upper slide spring felt weak by comparison to the lower slide spring.

Manufacturer Narrative

The reported complaint was confirmed as the tension felt weaker in comparison, however, a specification does not exist for the tension of the tube clamps.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 10992820
• MDR Text Key: 220960453
• Report Number: 1828100-2020-00476
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801040
• Device Catalogue Number: 801040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 02/16/2021; 04/06/2021
• Supplement Dates FDA Received: 03/10/2021; 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1